BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE/MARQUETTE

    MDR report key: 349777 · Received August 29, 2001

    Report

    Report Number
    MW1022749
    Event Type
    Malfunction
    Date Received
    August 29, 2001
    Date of Event
    August 23, 2001
    Report Date
    August 29, 2001
    Manufacturer
    MARQUETTE
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALARM FAILED TO NOTIFY STAFF AT CENTRAL MONITORS IN TELEMETRY UNIT, IE, NO AUDIO, NO VISUAL INDICATION, AND NO STRIP RECORDING. STAFF OBSERVED VENTRICULAR TACHYCARDIA EPISODE AND RESPONDED IMMEDIATELY. BACK UP MONITOR IN CRITICAL CARE UNIT DID ALARM EVENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/21/2001: CLINICAL INFO CENTER (CIC), CATALOG NUMBER 418779-004. AT THIS SITE THERE ARE BEDSIDE PT MONITORS CONNECTED VIA TELEMETRY (APEX PRO) TO A CIC (MAIN), WHICH ENABLES THE OUTPUT OF UP TO 16 BEDSIDE MONITORS TO BE DISPLAYED. ELSEWHERE IN THE FACILITY A SECOND (MIRROR) CIC DISPLAYS THE SAME INFO AS APPEARS ON THE MAIN CIC. EACH OF THESE UNITS RECEIVES SIGNALS FROM THE APEX PRO TELEMETRY SYSTEM. THE MAIN CIC IS LOCATED IN THE PCU AND THE MIRROR CIC IS IN THE ICU. THE REPORT PROVIDED BY THE END USER DESCRIBES THE EVENT AS FOLLOWS: THE PCU MONITOR TECH OBSERVED THE WAVEFORM FOR BED CHANGE FROM NORMAL SINUS RHYTHM TO VENTRICULAR TACHYCARDIA AS DISPLAYED ON THE CIC. TECH REPORTED THINKING THAT WAVEFORM ARTIFACT MAY BE OCCURRING BECAUSE THERE WAS NO ALARM ISSUED. AFTER SEVERAL SECONDS IT WAS DECIDED THAT A V-TACH WAS LIKELY OCCURRING ON THIS PT AND INTERVENTION WAS PRUDENT. ANOTHER NURSE IMMEDIATELY ENTERED THE PT'S ROOM, CONFIRMED THA A V-TACH CONDITION DID EXIST, AND RESUSCITATIVE EFFORTS WERE SUCCESSFULLY UNDERTAKEN. CONCURRENT WITH THESE EVENTS A NURSE AT THE ICU STATION (MIRROR CIC) REPORTED THAT THE APPRORIATE ALARMS WERE BEING ISSUED FOR THE PT IN THAT BED. EVENT LOGS FROM EACH OF THE CIC UNITS WERE CAPTURED AND ANALYZED. EACH DEVICE LOG INDICATES THAT THE V-TACH SIGNAL WAS DETECTED AND CRISIS ALARM SOUNDED. AN INTERNAL MEMO REPORTING THIS INFO IS ATTACHED. THE END USER PROVIDED ECG GRAPH STRIPS GENERATED BY THEIR CIC UNITS FOR ANALYSIS BY GEMS IT'S SENIOR ALGORITHM SPECIALIST. THE INTENT OF THIS PORTION OF THE OVERALL INVESTIGATION WAS TO DEFINE THE OPERATING PARAMETERS OF THE MONITORING EQUIPMENT AND IMPROVE THE END USER'S UNDERSTANDING OF THE TECHNICAL PRINCIPLES AND LIMITATIONS OF CURRENT STATE-OF-THE-ART HARDWARE AND SOFTWARE. THERE WERE NO RESULTANT DEATHS. RESUSCITATIVE EFFORTS PRECLUDED SERIOUS INJURY TO THE AFFECTED PT. THE DEVICE REMAINED IN USE AT THE CUSTOMER SITE. IT WAS SUBSEQUENTLY REMOVED AND RETURNED TO THE MFG SITE FOR MORE EXTENSIVE TESTING, WHICH CONTINUES. THOUGH THE DEVICE LOGS CLEARLY INDICATE THAT BOTH CIC UNITS OPERATED AS EXPECTED, THE END USER HAS BEEN RELUCTANT TO ACCEPT THIS EVIDENCE. REMOVAL AND REPLACEMENT OF UNIT WAS UNDERTAKEN AS PART OF GEMS IT'S ONGOING EFFORTS TO RESTORE CUSTOMER CONFIDENCE AND GOODWILL. THERE HAVE BEEN NO FURTHER REPORTS OF ALARM FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39182 GE/MARQUETTE CLINICAL INFORMATION CENTER DRT MARQUETTE CIC 41879-004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *